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OPEN LABEL, FOUR-PERIOD, TWO-SEQUENCE, FULLY-REPLICATED, RANDOMIZED, SINGLE DOSE COMPARATIVE STUDY TO ASSESS BIOEQUIVALENCE OF Polypill AAR 100/80/10 mg capsules FIXED DOSE COMBINATION (TEST) VERSUS EQUAL DOSES OF COADMINISTERED Aspirin® N 100mg tablets + Cardyl® 80mg film-coated tablets + Acovil® 10mg tablets (REFERENCE formulations) IN HEALTHY MALE AND FEMALE VOLUNTEERS UNDER FASTING CONDITIONS

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505572-30-00
Acronym
ARA-BESD-14-FRI/23
Enrollment
56
Registered
2023-10-20
Start date
2023-10-24
Completion date
2024-02-02
Last updated
2023-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Study performed on healthy volunteers

Interventions

None listed

Sponsors

Ferrer Internacional S.A.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Countries

Romania

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026